(64 days)
The DetachaTip® III Multi Use Instruments are intended for use in a variety of laparoscopic procedures to transect, dissect, grasp, and coagulate tissue.
The DetachaTip® III Multi Use Laparoscopic Instrument family comprises a series of sterile, multi-use laparoscopic scissors, graspers and dissectors designed to be used in conjunction with an appropriately sized cannula. All the instruments provide monopolar electrosurgical capability via a standard 4mm monopolar post. A single handle design accommodates 33cm and 43cm instrument shafts. Instrument shafts are available in a variety of blade or jaw configurations.
For graspers and dissectors, a lever on the handle allows the user to activate the ratcheting feature in a fixed ON/OFF position or an intermittent position. The ratcheting mode changes from intermittent to "OFF" once the user releases the lever. The ratcheting feature is intended for use with the grasper and dissector shafts only. The design of the scissors instrument shaft does not allow for ratcheting of those instruments.
A rotator knob on the instrument shaft allows for 360°axial rotation of the shaft and tip. The devices are designed with a Luer port located on the rotator knob that allows for flushing of the central shaft prior to steam sterilization.
The provided text describes a 510(k) summary for the ConMed® DetachaTip® III Multi-Use Laparoscopic Instrument, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a study that establishes acceptance criteria for novel performance claims. Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.
However, I can extract the available information and state what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in terms of quantitative criteria) | Demonstrated substantial equivalence to predicate devices. |
| Compliance with AAMI/ANSI ES60601-1:2005 and IEC 60601-2-2:2009 (Electrosurgical safety standards) | Devices comply with the applicable sections of these standards. |
| Compliance with ISO 10993-1:2009 (Biocompatibility/Material Safety) | Materials comply with the requirements of this standard. |
| Performance during non-clinical bench testing | Demonstrated substantial equivalence to Detacha-Tip Surgical Instruments regarding intended use, materials, technology, and performance. |
| Performance during simulated use testing | Demonstrated substantial equivalence to Detacha-Tip Surgical Instruments regarding intended use, materials, technology, and performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any specific test set. The document refers to "non-clinical bench and simulated use testing" without detailing the number of units tested.
- Data Provenance: Not specified. The testing described is non-clinical/bench-level and simulated use, not involving patient data or clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. The "ground truth" for the tests mentioned (safety standards compliance, substantial equivalence to predicate devices) is based on technical specifications and comparison, not expert consensus on diagnostic or clinical outcomes.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. The type of testing described (bench and simulated use for substantial equivalence) does not typically involve adjudication in the sense of resolving discrepancies between expert opinions on a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is a laparoscopic surgical instrument, not an AI or imaging diagnostic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This device is a surgical instrument that requires human operation; it is not an algorithm or a standalone automated system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the "substantial equivalence" claim, the ground truth is primarily based on technical specifications, material properties, and functional performance characteristics of the predicate devices. For parts of the testing, compliance to recognized consensus standards (AAMI/ANSI ES60601-1, IEC 60601-2-2, ISO 10993-1) serves as the "ground truth" for safety and material compatibility.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a physical surgical instrument, not an AI model or software algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.